“How will the new Tennessee pharmacy board regulations change the rules for pharmacy drug compounders?”
June 19, 2013
The Tennessee Pharmacy Board recently approved new regulations for compounding pharmacies in response to the fungal meningitis outbreak involving New England Compounding Center which sickened 745 people with 58 deaths.
The new regulations allow the state to:
- Take quicker action against a compounder's license when there is a safety issue,
- Create a separate licensing category for medicine manufacturers,
- Require proof that a manufacturer is registered with the FDA
- Require special registration for every pharmacy that performs sterile compounding.
These new regulations will take effect when the legal notices are published, possibly in July 2013. In addition to these regulations, more actions are being considered. In fact, the board obtained additional staff including three pharmacists and one administrative person to enforce the new regulations.
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